Package 0065-4011-05
Brand: zaditor
Generic: ketotifen fumaratePackage Facts
Identity
Package NDC
0065-4011-05
Digits Only
0065401105
Product NDC
0065-4011
Description
1 BOTTLE, DROPPER in 1 CARTON (0065-4011-05) / 5 mL in 1 BOTTLE, DROPPER
Marketing
Marketing Status
Brand
zaditor
Generic
ketotifen fumarate
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["OPHTHALMIC"], "spl_id": "bed738a0-2943-46e7-a65e-2440dac7971b", "openfda": {"upc": ["0300654011057"], "unii": ["HBD503WORO"], "rxcui": ["284380", "311237"], "spl_set_id": ["ac66b1e4-c2b0-a4c3-09e3-ebd44a2f7c9f"], "manufacturer_name": ["Alcon Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (0065-4011-05) / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "0065-4011-05", "marketing_start_date": "20130313"}, {"sample": false, "description": "2 BOTTLE, DROPPER in 1 CARTON (0065-4011-06) / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "0065-4011-06", "marketing_start_date": "20130108"}, {"sample": false, "description": "3 BOTTLE, DROPPER in 1 CARTON (0065-4011-11) / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "0065-4011-11", "marketing_start_date": "20150213"}], "brand_name": "Zaditor", "product_id": "0065-4011_bed738a0-2943-46e7-a65e-2440dac7971b", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Inhibitor [EPC]"], "product_ndc": "0065-4011", "generic_name": "ketotifen fumarate", "labeler_name": "Alcon Laboratories, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Zaditor", "active_ingredients": [{"name": "KETOTIFEN FUMARATE", "strength": ".25 mg/mL"}], "application_number": "ANDA077200", "marketing_category": "ANDA", "marketing_start_date": "20130108", "listing_expiration_date": "20261231"}